510(k) K170239
K170239 is an FDA 510(k) premarket notification submitted by Leica Microsystems (Schweiz) AG for the device "Leica FL560". The FDA issued a decision of Substantially Equivalent (kit, denovo) on July 5, 2017. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Leica Microsystems (Schweiz) AG has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- July 5, 2017
- Date Received
- January 26, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Angiographic
- Device Class
- Class II
- Regulation Number
- 892.1600
- Review Panel
- RA
- Submission Type